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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K922647
Device Name COLOR DISKSTORE
Applicant
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Applicant Contact SCOTT PEASE
Correspondent
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Correspondent Contact SCOTT PEASE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received06/03/1992
Decision Date 08/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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